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The U.S. Senate has unanimously passed two bipartisan bills aimed at lowering prescription drug prices by elevating generics and biosimilars that are now awaiting consideration in the House. Read More
India’s and South Africa’s proposal to temporarily waive intellectual property rights for COVID-19 vaccines and medicines was stopped once again by opposition from wealthy Western nations, including the U.S., during the World Trade Organization (WTO)’s meeting last week, in a victory for the pharma industry. Read More
The World Health Organization (WHO) issued an Emergency Use Listing on Friday for Johnson & Johnson’s one-shot COVID-19 vaccine — a step that clears the way for the COVAX global vaccine-sharing program to begin distributing the shot to poorer countries hardest hit by the pandemic. Read More
Sanofi Pasteur and Translate Bio are working together on a COVID-19 vaccine candidate that uses messenger-RNA (mRNA) technology and should be easier to store than Moderna’s and Pfizer/ BioNTech’s mRNA-based vaccines. Read More
Novavax said its COVID-19 vaccine demonstrated 96.4 percent efficacy against mild, moderate and severe forms of the original SARS-CoV-2 strain in the final analysis from its phase 3 UK trial. Read More
AstraZeneca (AZ) could be ready to request Emergency Use Authorization (EUA) from the FDA for its COVID-19 vaccine before the end of the month as its U.S. phase 3 trial nears having enough data to adequately assess its efficacy. Read More
Vir Biotechnology and GlaxoSmithKline’s monoclonal antibody for COVID-19 reduced hospitalizations or death from the infection by 85 percent in a phase 3 trial, according to the companies — and they have stopped enrollment in the trial because of the therapy’s “profound efficiency.” Read More
Roche reported that its arthritis drug Actemra (tocilizumab), when paired with the antiviral remdesivir (Veklury) from Gilead Sciences, did not meet the endpoint of improved time to hospital discharge for patients with severe COVID-19 pneumonia. Read More
As part of an industry-wide FDA review, the agency’s Oncologic Drugs Advisory Committee will convene next month to discuss six cancer indication approvals given under the agency’s Accelerated Approval program that haven’t verified their clinical benefit in confirmatory trials as required. Read More
Pfizer and BioNTech announced yesterday that their vaccine was 94 percent effective in preventing asymptomatic COVID-19 infection, based on real-world data from Israel, indicating it could greatly reduce transmission from person to person. Read More